Coronary Microvascular DiseaseNCT04321434
Hyperoxia and Microvascular Dysfunction
A study testing Hyperoxia, Normoxia and laser Doppler in people with Coronary Microvascular Disease and Microvascular Disease, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
Coronary artery disease (CAD) pathophysiology involves endothelium-dependent (e.g. nitric oxide, acetylcholine) and -independent (e.g. adenosine) vascular dilation impairment, which have been demonstrated at the level of small coronary arteries, medium sized peripheral arteries and subcutaneous microcirculation. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Microvascular Disease, Microvascular Disease, Ischemic Heart Disease
- What is being tested?
- Hyperoxia, Normoxia and laser Doppler
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2016to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Coronary angiography done in the context of suspicion of coronary artery disease (CAD)
Who cannot join
- Respiratory failure requiring intubation or supplementary oxygen
- Severe chronic obstructive pulmonary disease
- Significant arrhythmia precluding waveform analysis (e.g., excessive premature ventricular contractions or atrial fibrillation)
- Severe valvular heart disease,
- Suspected elevated central venous pressure (CVP)
- Heart failure as defined by New York Heart Association class III or IV
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- Previous coronary revascularization or heart transplantation
- Severe hypertension (systolic pressure >200 mmHg and diastolic pressure >120 mmHg at rest)
- Contraindications to adenosine infusion
- Contraindication to acetylcholine (Ach) infusion
- Severe bronchial asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac and Subcutaneous Microvascular Dysfunction in Patients With Ischemic Heart Disease: Effects of an Acute Oxidative Stress
Coronary artery disease (CAD) pathophysiology involves endothelium-dependent (e.g. nitric oxide, acetylcholine) and -independent (e.g. adenosine) vascular dilation impairment, which have been demonstrated at the level of small coronary arteries, medium sized peripheral arteries and subcutaneous microcirculation. Oxygen supplementation, which is frequently overused in clinical settings, seems harmful in acute coronary syndromes and increases microvascular resistance in myocardial and subcutaneous microcirculation through alteration of endothelium-dependent and -independent dilation by an oxidative mechanism. Whether endothelial dysfunction, that is well documented at the level of cardiac microcirculation in CAD patients, is also present at the level of subcutaneous microcirculation is unknown. Also, unknown is whether an acute oxidative stress can be used to probe myocardial microcirculatory dysfunction at the level of subcutaneous microcirculation, which is an easily accessible vascular bed for an in vivo assessment of endothelial-dependent and-independent function. Alterations in cutaneous vascular signalling are evident early in the disease processes. Thus, studying subcutaneous circulation in patients with cardiovascular risk factors could provide vascular information early in CAD processes. This study will test the following 4 hypotheses:
- Endothelial dysfunction observed at the level of microvascular cardiac arteries is readily present at the level of subcutaneous microcirculation in a given CAD patient.
- An acute oxidative stress such as hyperoxia can be used to test myocardial microcirculatory dysfunction at the level of the more easily accessible subcutaneous microcirculation.
- Subcutaneous microcirculation of CAD patients has a lesser vasodilatory response to acetylcholine or sodium nipride than matched healthy subjects. In addition, CAD patients are more prone to dermal vasoconstriction in response to oxygen compared to healthy subjects.
- Taken that oxygen is still too often given in excess in most clinical settings, the aim of this study is to rule out possible pitfalls in coronary pressure and resistance determinations in CAD patients receiving unnecessary oxygen supplementation.
- Being tested
- Hyperoxia, Normoxia, laser Doppler
- Keywords
- cardiac microvascular dysfunction, subcutaneous microvascular dysfunction, ischemic heart disease, oxydative stress
- Medical subject headings
- Microvascular Angina, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperoxiaOther
NormoxiaOther
laser DopplerDevice
laser Doppler
| Study group | Role | What they receive |
|---|---|---|
| Hyperoxia | Experimental | * assessment of forearm skin microcirculatory blood flow by laser Doppler perfusion imager at baseline and during hyperemic tests
* assessment of coronary microcirculatory blood flow at baseline and during hyperemic tests Receives: Other: Hyperoxia; Device: laser Doppler |
| Normoxia | Placebo comparator | * assessment of forearm skin microcirculatory blood flow by laser Doppler perfusion imager at baseline and during hyperemic tests
* assessment of coronary microcirculatory blood flow at baseline and during hyperemic tests Receives: Other: Normoxia; Device: laser Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the acetylcholine-induced skin blood flow after hyperoxia
Measurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units).
Measured: 1 hour
Change from baseline in the sodium nitroprusside-induced skin blood flow after hyperoxia
Measurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units).
Measured: 1 hour
Change from baseline in the heat-induced skin blood flow after hyperoxia
Measurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units).
Measured: 1 hour
Change from Baseline in the index of microcirculatory resistance Under adenosine after hyperoxia
Measurement of coronary microcirculatory resistance (index of microcirculatory resistance) Under adenosine before and after hyperoxia, expressed in arbitrary units
Measured: 10 minutes
Change from Baseline in the index of microcirculatory resistance at rest after hyperoxia
Measurement of coronary microcirculatory resistance (index of microcirculatory resistance) at rest before and after hyperoxia, expressed in arbitrary units
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Dec 2016
- Primary completion1 Apr 2018
- Study completion1 Oct 2018
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Chaumont, Université Libre de Bruxelles
- Investigators
- Jean-Paul Van Vooren, MD, PhD, Study director, Hospital Erasme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321434
- Sponsor's protocol ID
- P2016/043/B406201627021
- Status last verified
- Mar 2020
- First submitted
- 16 Jan 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac and Subcutaneous Microvascular Dysfunction in Patients With Ischemic Heart Disease: Effects of an Acute Oxidative Stress
- ClinicalTrials.gov ID
- NCT04321434
- Acronym / sponsor ID
- P2016/043/B406201627021
- Keywords
- cardiac microvascular dysfunction, subcutaneous microvascular dysfunction, ischemic heart disease, oxydative stress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 1 Dec 2016
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary artery disease (CAD) pathophysiology involves endothelium-dependent (e.g. nitric oxide, acetylcholine) and -independent (e.g. adenosine) vascular dilation impairment, which have been demonstrated at the level of small coronary arteries, medium sized peripheral arteries and subcutaneous microcirculation. Oxygen supplementation, which is frequently overused in clinical settings, seems harmful in acute coronary syndromes and increases microvascular resistance in myocardial and subcutaneous microcirculation through alteration of endothelium-dependent and -independent dilation by an oxidative mechanism. Whether endothelial dysfunction, that is well documented at the level of cardiac microcirculation in CAD patients, is also present at the level of subcutaneous microcirculation is unknown. Also, unknown is whether an acute oxidative stress can be used to probe myocardial microcirculatory dysfunction at the level of subcutaneous microcirculation, which is an easily accessible vascular bed for an in vivo assessment of endothelial-dependent and-independent function. Alterations in cutaneous vascular signalling are evident early in the disease processes. Thus, studying subcutaneous circulation in patients with cardiovascular risk factors could provide vascular information early in CAD processes. This study will test the following 4 hypotheses:
- Endothelial dysfunction observed at the level of microvascular cardiac arteries is readily present at the level of subcutaneous microcirculation in a given CAD patient.
- An acute oxidative stress such as hyperoxia can be used to test myocardial microcirculatory dysfunction at the level of the more easily accessible subcutaneous microcirculation.
- Subcutaneous microcirculation of CAD patients has a lesser vasodilatory response to acetylcholine or sodium nipride than matched healthy subjects. In addition, CAD patients are more prone to dermal vasoconstriction in response to oxygen compared to healthy subjects.
- Taken that oxygen is still too often given in excess in most clinical settings, the aim of this study is to rule out possible pitfalls in coronary pressure and resistance determinations in CAD patients receiving unnecessary oxygen supplementation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperoxia | Experimental | Other: Hyperoxia, Device: laser Doppler* assessment of forearm skin microcirculatory blood flow by laser Doppler perfusion imager at baseline and during hyperemic tests * assessment of coronary microcirculatory blood flow at baseline and during hyperemic tests |
| Normoxia | Placebo comparator | Other: Normoxia, Device: laser Doppler* assessment of forearm skin microcirculatory blood flow by laser Doppler perfusion imager at baseline and during hyperemic tests * assessment of coronary microcirculatory blood flow at baseline and during hyperemic tests |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Coronary angiography done in the context of suspicion of coronary artery disease (CAD)
Key exclusion criteria (11 listed)
- Respiratory failure requiring intubation or supplementary oxygen
- Severe chronic obstructive pulmonary disease
- Significant arrhythmia precluding waveform analysis (e.g., excessive premature ventricular contractions or atrial fibrillation)
- Severe valvular heart disease,
- Suspected elevated central venous pressure (CVP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperoxia | Other | Hyperoxia |
| Normoxia | Other | Normoxia |
| laser Dopplerlaser Doppler | Device | Hyperoxia, Normoxia |
Primary outcome
Change from baseline in the acetylcholine-induced skin blood flow after hyperoxia
Time frame: 1 hour
Measurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units).
Change from baseline in the sodium nitroprusside-induced skin blood flow after hyperoxia
Time frame: 1 hour
Measurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units).
Change from baseline in the heat-induced skin blood flow after hyperoxia
Time frame: 1 hour
Measurement of skin blood flow before, during and after hyperoxia, expressed in perfusion units (arbitrary units).
Change from Baseline in the index of microcirculatory resistance Under adenosine after hyperoxia
Time frame: 10 minutes
Measurement of coronary microcirculatory resistance (index of microcirculatory resistance) Under adenosine before and after hyperoxia, expressed in arbitrary units
Change from Baseline in the index of microcirculatory resistance at rest after hyperoxia
Time frame: 10 minutes
Measurement of coronary microcirculatory resistance (index of microcirculatory resistance) at rest before and after hyperoxia, expressed in arbitrary units
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No
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Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Paul Van Vooren, MD, PhD study director
Hospital Erasme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperoxia, Normoxia and laser Doppler in people with Coronary Microvascular Disease and Microvascular Disease, run by Université Libre de Bruxelles at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the acetylcholine-induced skin blood flow after hyperoxia (time frame: 1 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.